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Gamma Secretase Inhibitor

Varegacestat + Itraconazole Interaction Study in Healthy Subjects

Phase 1
Recruiting
Led By Michelle Valentine
Research Sponsored by Immunome, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy, adult, male or female (of non-childbearing potential only), 18 to 55 years of age, inclusive, at the screening visit
Be between 18 and 65 years old
Must not have
Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 months
Awards & highlights
No Placebo-Only Group

Summary

This trial involves studying how two drugs interact with each other in healthy participants.

Who is the study for?
This trial is for healthy individuals who can participate in a study to understand how the drug Varegacestat interacts with Itraconazole. Specific eligibility criteria are not provided, but typically participants must be adults without any significant health issues.
What is being tested?
The study is testing the effects of Itraconazole on the body's response to a single dose of Varegacestat. It's an open-label and crossover study, meaning everyone knows what treatment they're getting and participants will receive both drugs at different times.
What are the potential side effects?
Possible side effects aren't detailed here, but common ones for Itraconazole include nausea, rash, and liver enzyme changes. Varegacestat may have its own set of side effects which would be monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a healthy adult between 18 and 55 years old and cannot have children.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am mentally capable and do not have significant emotional issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effect of itraconazole on the PK of varegacestat in healthy participants.
Secondary study objectives
Ctrough of itraconazole and hydroxy-itraconazole in combination with varegacestat in healthy participants.
Safety and tolerability of varegacestat in the presence of itraconazole in healthy participants.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment2 Interventions
Period 1: varegacestat administration for PK followed by Period 2: itraconazole and varegacestat administration for PK and DDI
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itraconazole (200 mg)
2017
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Immunome, Inc.Lead Sponsor
2 Previous Clinical Trials
201 Total Patients Enrolled
Michelle ValentinePrincipal InvestigatorCelerion
~15 spots leftby Jan 2025
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